Roche 9180 - Material: ISETROL Protein Based Aqueous Control Material (Level 1), N=80; Measurement Parameters; Performance Parameters; Reproducibility

Roche Diagnostics
Instructions for Use · Version 10.0 35
9180 Electrolyte Analyzer 3 Specifications
Performance parameters
Performance parameters
Measurement parameters
Reproducibility
Typical within-run (S
wr
), between-day (S
dd
) and total (S
T
) precision is determined
from 2 runs per day with 2 replicates per run for 20 days on
2 9180 Electrolyte Analyzers. Values for sodium and potassium are the average of all
instruments. Values of chloride, calcium, and lithium are determined from the
measurement of two of each respective unit configuration. All values are reported in
mmol/L.
Material: ISETROL Protein Based Aqueous Control Material (Level 1), n=80
specified for: specified range:
Na
+
B/S/Q 40 - 205 mmol/L
U 1 - 300 mmol/L
K
+
B/S/Q 1.5 - 15 mmol/L
U 4.5 - 120 mmol/L
U* 60 - 120 mmol/L
Cl
-
B/S/Q 50 - 200 mmol/L
U 1 - 300 mmol/L
Ca
2+
B/S/Q 0.2 - 5.0 mmol/L
Li
+
S/Q 0.1 - 6.0 mmol/L
Table 3-1
B whole blood
S serum or plasma
Q aqueous QC material
U urine samples (dilution required, see Urine samples (p. 111))
U* urine samples (second dilution required, see Urine samples (p. 111))
Parameter Mean S
wr
(CV %) S
dd
(CV %) S
T
(CV %)
Sodium 114.6 0.48 0.42 0.76 0.66 0.89 0.78
Potassium 2.82 0.025 0.87 0.035 1.24 0.041 1.44
Chloride 76.7 0.29 0.38 0.52 0.67 0.72 0.94
Calcium 2.07 0.015 0.72 0.024 1.18 0.034 1.66
Lithium 0.40 0.010 2.40 0.018 4.57 0.026 6.41
Table 3-2